EUROFER REACH guidance for the European Steel Industry. 09.09 ...

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REACH Guidance for the European Steel Industry • must apply the risk management measures identified by the supplier and communicated to them via Safety Data Sheets (SDS) and pass this information down the supply chain; and • should make their suppliers aware of how they use each substance so that the supplier can include these uses in the risk assessment and risk management information in the SDS. REACH contains a number of terms and definitions which are referenced throughout the document. A list of key definitions is provided in Annex I and a glossary of terms in Annex II of this Eurofer REACH guidance. Where possible, the key articles extracted from the REACH Regulation have been included as a further source of information. Useful web links are provided in Annex III of this guidance. 2 The REACH Process 2.1 Pre-registration Pre-registration is one of the key stages of the REACH process, which takes place between 1 June 2008 and 1 December 2008. During this period, manufacturers and importers may in accordance with Article 28 provide the following information concerning the substances that they intend to register: • The name of the substance; • EINECS and CAS numbers of the substance or, if not available, other identity codes; • The name and address of the potential registrant (i.e. manufacturer, importer or person representing them); • The name of the contact person; and • The envisaged deadline for the registration and the tonnage band. Pre-registrants may, as a further option, provide any information that already exists regarding computer predictions of the toxicity of the substance (QSARs) or toxicological properties that are predicted by comparing the substance to ones with a similar chemical structure. Pre-registration does not mean that there is an obligation to register the substance within the deadlines set for the relevant tonnage bands. However, manufacturers and importers who fail to pre-register will not be entitled to take advantage of the transitional periods for registration (i.e. they must cease manufacture, import and placing of their substance on the market unless a registration is made). Pre-registration applies to “phase-in” substances (i.e. existing substances with EINECS and/or CAS numbers already placed on the EU market). Hence, manufacturers and importers of new substances and phase-in substances that are not pre-registered will be required to register, in full, 12 months after REACH enters into force (i.e. 1 June 2008). Thus, any manufacturer or importer who fails to pre-register its “phase-in” substances will not be able to rely on support from Substance Information Exchange Forums (SIEFs), making registration of a substance potentially both onerous and expensive. Pre-registered information will only be available to those who have pre-registered the same substance (i.e. SIEFs). When pre-registering a “phase-in” substance, the manufacturer or importer can tick the option to be the SIEF formation facilitator. This option is available on a first come, first-serve basis. De-activation of a pre-registerion of a substance is available closure of the pre-registration period.. After the pre-registration period has closed, the legal entity will become part of the SIEF – meaning its data-sharing obligations will be retained. However, a legal entity may indicate it no longer intends to register and it wishes to be a dormant SIEF members. This arrangement is to avoid that pre-registration simply to find out who else has pre-registered the same substance. A legal entity will be able to re-activate its pre-registration if it wishes to do so. September 2009 6
REACH Guidance for the European Steel Industry It is expected that some manufactures and/or importers may decide to withdraw substances from the market rather than undergo the burden of pre-registration and registration, while other manufacturers and/or importers with SVHC subject to an authorisation or with substances subject to restriction may also decide to withdraw from the market. For downstream users (DUs), this may necessitate seeking alternative suppliers or substances for product use. It is also anticipated that some downstream users may seek not to disclose their intended use to a manufacturer and/or importer and notify the use of a substance with ECHA directly, thus preserving the confidentiality of that commercial use. 2.2 Substance Information Exchange Forums (SIEFs) On 1 January 2009, 1 month after the pre-registration phase has ended, the European Chemicals Agency (ECHA), which is responsible for coordinating registration at community level, will publish a list of the substances pre-registered on its website. The list will comprise only the names of the substances, including their EINECS and CAS numbers if available and other identity codes, and the first envisaged registration deadline. Any manufacturer or importer who pre-registers can expect to rely on support from SIEFs, which are to be formed by pre-registrants after the preregistration phase ends. In accordance with REACH Article 29, SIEFs will be formed by groups of producers, importers and downstream users of the same substance with the following aims:- (a) facilitate, for the purposes of registration, the exchange of specified information between potential registrants in order to avoid the duplication of studies; and (b) agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants. SIEF participants are obliged to provide other participants with existing animal studies, react to requests by other participants for information, collectively identify the need for further studies and arrange for such studies to be carried out. The sharing of test data on vertebrate animals is a mandatory requirement of REACH. Furthermore, in accordance with Article 11, REACH encourages SIEF members to make joint submissions of certain data via a Lead Registrant (to be appointed by the SIEF members). These provisions are intended to reduce the cost of registration and assessment of substances for individual legal entities. Detailed guidance on data sharing, the operation of SIEFs, the role of Lead Registrants and joint submissions are to be found on the ECHA REACH Navigator website. Furthermore, CEFIC published in June 2008 its guidance on SIEF Formation. It is important to differentiate the legal status of SIEFs and consortia. SIEFs are a legal requirement and, as such, manufacturers and importers that have pre-registered “phase-in” substances will automatically be placed in the relevant SIEF(s). Later, other data holders (e.g. DUs, NGOs, universities, etc) may join the SIEF. For manufacturers ands importers that have preregistered “phase-in” substances, participation in a SIEF is mandatory (unless specific criteria can be met). In contrast, membership of a consortium is purely voluntary and it should be noted that the REACH Regulation does not address the formation of consortia, although they are addressed in the REACH guidance on data sharing. Consortia may be formed at any time during the REACH process (i.e. prior to, and after, pre-registration). Therefore, SIEF members may decide that it would be advantageous to form a consortium to share the cost of data gathering, testing and/or preparation of the Chemical Safety Report for their substance. It is also important to note that a SIEF will only be formally established when its members have agreed and informed ECHA that they are manufacturers or importers of the same substance. Once again, the REACH guidance documents on substance identification and data sharing should be consulted in order to establish the “sameness” of the substance and rules for forming SIEFs. Each SIEF remain operational until 1 June 2018. September 2009 7
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